First, thank you Dr. Krause for being wiiiing to speak in this oodcast.
How do well do you feel Peter Marks did with handling concerns brought to FDA’s attention with respect to adverse reactions during the vaccine clinical trials and after the covid vaccines received EUA approval?
With respect to that question, what would happen if a clinical trial participant was misdiagnosed by doctors during a covid vaccine trial? Would it be re-evaluated for causation and how is causation determined? Did this happen at all during the covid vaccine clinical trials?
If there were any serious adverse reactions during the covid vaccine clinical trials does the FDA review the case and medical records or rely solely on the opinion of the PI and pharmaceutical company? If it is the latter, does the FDA have a way to confirm the data they provide the FDA for the participants adverse reaction, diagnosis and causality is accurate?
What options does Krause think the government needs to develop for disciplining and potentially firing officials like Marks who create conflicts of interest and override agency procedures?
I was actually quite taken aback during the first interview regarding Dr. Krause's statement that the novel vaccine was universally indicated for all adults because "myocarditis is more common following covid infection than following vaccination". Rav, you did a good job rebutting that statement, particularly by pointing out that many of the "myocarditis" cases associated with SARS-CoV-2 infection were actually related to cardiac marker elevation or EKG abnormalities in (generally older) critically ill hospitalized patients with multi-system injury, not stand-alone cases of myocarditis, as typically seen in young vaccine-injured patients. Perhaps more critically, the statement is not valid in a more important way. When considering whether the risk-benefit ratio favors vaccination, it is necessary to look at the risk of myocarditis in two groups:
1-A vaccinated group, in which every individual is receiving therapy and therefore exposed to the risk of myocarditis.
2-A second group of a like-number of individuals who might contract covid. Not everyone in this comparison group will contract covid, unlike the 100% of those in the vaccinated group who will receive the vaccine.
Also, one MUST consider that at the time these deliberations were occurring, many people had already recovered from covid, therefore completely altering the risk-benefit ratio.
Additionally, of course, it is imperative to risk-stratify for age.
The nuanced comparison that needed to be made was something like this:
-if you gave two doses the vaccine to 10,000 young healthy individuals in mid-2021, how many of them would develop vaccine-induced myocarditis vs...
-if 10,000 young healthy individuals at that same stage of the pandemic chose not to be vaccinated, how many of them would....a) go on to contract Covid during a specified comparative timeframe AND b) then go on to develop Covid induced myocarditis.
I'm not an epidemiologist or a vaccinologist (and neither is Dr. Marks), but this seems plainly obvious to me. Perhaps Dr. Krause could expand on your previous discussion, and also address wherever or not Dr. Marks was involved with or attempted to influence the decision making regarding approval.
As a second question: Does Dr. Krause believe that it is appropriate for employees of the NIH to be financially incentivized (either directly or indirectly) by pharmaceutical companies? How can the public have faith that their public health officials (or approval board members) are acting in the best interest of the citizens if they are potentially financially conflicted?
I'd like to extend a thank you in advance to Dr. Krause.
The FDA has the Emergency Use Authorization pathway to get life-saving drugs onto the market quickly. Why doesn't the FDA grant EUA approvals to other drugs that have demonstrated efficacy against fatal diseases? For example, babies with severe LAD-I can survive for at most two years. There's a drug in development, Kresladi, that has shown good efficacy and safety in these patients. The FDA has not given Kresladi approval, even long after the PDUFA date. Should the FDA give Kresladi an EUA?
About 160 million people received mRNA COVID-19 vaccines before those products received full approval from the FDA. Essentially, the FDA said it’s okay with Americans receiving drugs that hadn’t been fully evaluated by the FDA. If that is true, why does any drug ever need to be fully evaluated by the FDA? Why can’t all approvals be simpler EUA-type approvals?
As a pathologist, I was concerned about the use of PCR testing, with amplification up to 30x reported as "Positive" as a screening test and used to exclude individuals from travel, sports, work, etc. What was the rationale for widespread use of PCR testing as a screening test for COVID? Who decided the threshold for a "positive" diagnosis? Did this wildly overstate the extent of COVID in the population?
First, thank you Dr. Krause for being wiiiing to speak in this oodcast.
How do well do you feel Peter Marks did with handling concerns brought to FDA’s attention with respect to adverse reactions during the vaccine clinical trials and after the covid vaccines received EUA approval?
With respect to that question, what would happen if a clinical trial participant was misdiagnosed by doctors during a covid vaccine trial? Would it be re-evaluated for causation and how is causation determined? Did this happen at all during the covid vaccine clinical trials?
If there were any serious adverse reactions during the covid vaccine clinical trials does the FDA review the case and medical records or rely solely on the opinion of the PI and pharmaceutical company? If it is the latter, does the FDA have a way to confirm the data they provide the FDA for the participants adverse reaction, diagnosis and causality is accurate?
Thank you!
What options does Krause think the government needs to develop for disciplining and potentially firing officials like Marks who create conflicts of interest and override agency procedures?
I was actually quite taken aback during the first interview regarding Dr. Krause's statement that the novel vaccine was universally indicated for all adults because "myocarditis is more common following covid infection than following vaccination". Rav, you did a good job rebutting that statement, particularly by pointing out that many of the "myocarditis" cases associated with SARS-CoV-2 infection were actually related to cardiac marker elevation or EKG abnormalities in (generally older) critically ill hospitalized patients with multi-system injury, not stand-alone cases of myocarditis, as typically seen in young vaccine-injured patients. Perhaps more critically, the statement is not valid in a more important way. When considering whether the risk-benefit ratio favors vaccination, it is necessary to look at the risk of myocarditis in two groups:
1-A vaccinated group, in which every individual is receiving therapy and therefore exposed to the risk of myocarditis.
2-A second group of a like-number of individuals who might contract covid. Not everyone in this comparison group will contract covid, unlike the 100% of those in the vaccinated group who will receive the vaccine.
Also, one MUST consider that at the time these deliberations were occurring, many people had already recovered from covid, therefore completely altering the risk-benefit ratio.
Additionally, of course, it is imperative to risk-stratify for age.
The nuanced comparison that needed to be made was something like this:
-if you gave two doses the vaccine to 10,000 young healthy individuals in mid-2021, how many of them would develop vaccine-induced myocarditis vs...
-if 10,000 young healthy individuals at that same stage of the pandemic chose not to be vaccinated, how many of them would....a) go on to contract Covid during a specified comparative timeframe AND b) then go on to develop Covid induced myocarditis.
I'm not an epidemiologist or a vaccinologist (and neither is Dr. Marks), but this seems plainly obvious to me. Perhaps Dr. Krause could expand on your previous discussion, and also address wherever or not Dr. Marks was involved with or attempted to influence the decision making regarding approval.
As a second question: Does Dr. Krause believe that it is appropriate for employees of the NIH to be financially incentivized (either directly or indirectly) by pharmaceutical companies? How can the public have faith that their public health officials (or approval board members) are acting in the best interest of the citizens if they are potentially financially conflicted?
Respectfully,
Chris Robben, MD
I'd like to extend a thank you in advance to Dr. Krause.
The FDA has the Emergency Use Authorization pathway to get life-saving drugs onto the market quickly. Why doesn't the FDA grant EUA approvals to other drugs that have demonstrated efficacy against fatal diseases? For example, babies with severe LAD-I can survive for at most two years. There's a drug in development, Kresladi, that has shown good efficacy and safety in these patients. The FDA has not given Kresladi approval, even long after the PDUFA date. Should the FDA give Kresladi an EUA?
About 160 million people received mRNA COVID-19 vaccines before those products received full approval from the FDA. Essentially, the FDA said it’s okay with Americans receiving drugs that hadn’t been fully evaluated by the FDA. If that is true, why does any drug ever need to be fully evaluated by the FDA? Why can’t all approvals be simpler EUA-type approvals?
I am already a paying person and have paid $80 dollars to subscribe. I am not allowed to listen Dr. Krause's 2nd interview?
Not released yet! Full first interview on Rumble:
https://rumble.com/v6raq68-former-fda-official-dr.-philip-krause-on-white-house-pressure-to-approve-co.html
What was the FDA’s justification for its war on ivermectin; which was widely recognize as an extremely safe human medication???
(Actually OTC in many countries until Covid)
What was the point of the FDA’s disinformation campaign against the use of ivermectin in Covid-19 viral infections???
Was the FDA unaware of the numerous studies (Over 100) demonstrating effectiveness in Covid-19 prevention and treatment???
Was there no internal debate in this regard???
In your opinion, were FDA’s action primarily based in malice or ignorance???
Respectfully
Eduardo Balbona MD
As a pathologist, I was concerned about the use of PCR testing, with amplification up to 30x reported as "Positive" as a screening test and used to exclude individuals from travel, sports, work, etc. What was the rationale for widespread use of PCR testing as a screening test for COVID? Who decided the threshold for a "positive" diagnosis? Did this wildly overstate the extent of COVID in the population?